AngioSculpt PTCA RX Scoring Balloon Catheter 2200-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132021153), received between Oct 12, 2018 and May 2, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P050018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2019Deflation Problem; Deflation Problem

  THE ANGIOSCULPT DEVICE WAS UNABLE TO DEFLATE COMPLETELY AFTER THE FIRST INFLATION. THE BALLOON WAS CAREFULLY REMOVED FROM INSIDE THE PATIENT'S BODY. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574207 ↗
• InjuryOct 12, 2018Unraveled Material; Unraveled Material

  THE ANGIOSCULPT DEVICE WAS USED TOGETHER WITH A ASAHI, PROWATER 0.014" GUIDE WIRE AND A MEDTRONIC, EBU 6F GUIDE CATHETER. THE ANGIOSCULPT WAS ATTEMPTED TO BE DELIVERED TO THE TORTUOUS ANATOMY BY PUSHING AND TWISTING, BUT UNABLE TO DELIVER. THE GUIDE WIRE WAS REMOVED AND SWITCHED TO DIFFERENT WIRE (BRAND UNKNOWN), BUT STILL UNABLE TO DELIVER, THUS THE GUIDE WIRE AND DEVICE WERE REMOVED AS A UNIT. UPON REMOVAL, THE BALLOON SHAFT WAS UNRAVELED. NO COMPLICATIONS TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P050018. One submission often covers many models, so check the product and lot details in each record.

• Z-0576-2020 · Dec 7, 2018 · Terminated
  Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics
• Z-2218-2010 · Dec 4, 2009 · Terminated
  AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter
• Z-0591-2008 · Nov 13, 2007 · Terminated
  AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.